Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits

NCT04823390 | Completed Phase 1 DMC

• 1 other identifier: MD-18-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative anxiety has many hazards and should be eliminated. Patients undergoing ophthalmologic procedures often undergo it under local anesthesia. In a trial to improve patients' satisfaction sedation is given. Sedation could be given either by an anesthetist or patient-controlled methods. This study compared both methods of sedation in terms of safety, depth of sedation, and patient satisfaction.

Conditions

Patient Satisfaction

Keywords

PCS

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction assessed by 7 point Likert scale.

  Assessed by 7 point Likert scale (ranging from 1 as minimum value and 7 as maximal value), higher value is better.

  Intraoperative for 1 hour.

Secondary Outcomes (7)

• Systolic and diastolic blood pressures.

  Intraoperative for 1 hour.

• Surgeons' satisfaction assessed by 7 point Likert scale.

  Intraoperative for 1 hour.

• Patient's anxiety assessed by State trait anxiety inventory.

  Intraoperative for 1 hour.

• Heart rate.

  Intraoperative for 1 hour.

• Oxygen saturation.

  Intraoperative for 1 hour.

Study Arms (2)

Anesthetist controlled group

OTHER

15 patients undergoing cataract surgery will receive sedation given by the anesthetist together with local anesthesia according to the depth of sedation in the form of intravenous Midazolam and Fentanyl.

Drug: Midazolam-Fentanyl combination

Patient-controlled group

OTHER

15 patients undergoing cataract surgery under local anesthesia will administer sedation to themselves through a pump.

Drug: Midazolam-Fentanyl combination

Interventions

Midazolam-Fentanyl combination DRUG

Sedation is given to patients undergoing cataract surgery under local anesthesia

Anesthetist controlled group; Patient-controlled group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I, II.
• Age group 40-65 years old.
• Co-operative patients aware of the instructions.

You may not qualify if:

• Diagnosis of cognitive impairment or mental disorder.
• Hypersensitivity to any of the used drugs.
• Contraindication to local anesthesia e.g. Coagulation disorder.
• Severe pulmonary disease e.g. (obstructive sleep apnea).
• Use of sedative medications within the previous month.
• Chronic renal and cardiac disorder e.g. (chronic renal failure, heart failure).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty Of Medicine Kasr Al-Ainy Cairo University

Cairo, Cairo Governorate, 11865, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anaesthesia, surgical ICU and pain management kasr al aini

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: September 14, 2019
• Primary Completion: February 20, 2021
• Study Completion: February 24, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)